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Wednesday, June 03, 2020

GlaxoSmithKline to discontinue Zinetac tablets in India

The company has made a decision to discontinue the manufacture and supply of Zinetac tablets (150 mg and 300 mg products) manufactured in India and will in due course request cancellation of the marketing authorisation associated with the drug, GlaxoSmithKline Pharmaceuticals said in a regulatory filing.

By: PTI | New Delhi | Updated: May 22, 2020 2:44:52 pm
The headquarter offices of Glaxosmithkline Plc stand in the Brentford district of London, UK, on Wednesday, Dec. 19, 2018. Photographer: Luke MacGregor/Bloomberg

GlaxoSmithKline Pharmaceuticals on Thursday said it has decided to discontinue production and sale of Zinetac tablets, used to treat and prevent heartburn, in the country.

The company has made a decision to discontinue the manufacture and supply of Zinetac tablets (150 mg and 300 mg products) manufactured in India and will in due course request cancellation of the marketing authorisation associated with the drug, GlaxoSmithKline Pharmaceuticals said in a regulatory filing.

In the coming months, the drug firm will work closely with the regulatory authorities, it added.

The drug firm was contacted by regulatory authorities regarding the detection of cancer causing N-Nitrosodimethylamine (NDMA) in Zinetac (ranitidine) products.

Based on the information received and correspondence with regulatory authorities, the company made the decision in September 2019 to initiate a voluntary recall of all ranitidine products in all markets of as a precautionary action.

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